Martinsried/Munich (Germany), Waltham, Mass. and Princeton, N.J., December 9, 2005 - GPC Biotech AG (Frankfurt Stock Exchange: GPC; TecDAX index; NASDAQ: GPCB) today announced that a Phase 2 study evaluating the Company’s lead drug candidate, satraplatin, in combination with Taxol(r) (paclitaxel) as a first-line therapy in patients with unresectable advanced non-small cell lung cancer (NSCLC) has opened for accrual. Satraplatin is currently in a Phase 3 registrational trial as a second-line chemotherapy treatment for patients with hormone-refractory prostate cancer. The Company is also opening new clinical studies to explore the potential of satraplatin in a number of additional tumor types.
The Phase 2 study in advanced NSCLC is an open label study being led by investigators at the Sarah Cannon Research Institute (SCRI) in Nashville, Tennessee. The study will also be open for accrual in their affiliated network of oncologists, Tennessee Oncology. The primary objective of this study is to determine the objective response rate of satraplatin in combination with Taxol in this patient population. The study will also examine time to progression and overall survival. The study is expected to enroll up to 40 patients.
“I look forward to further exploring the potential of satraplatin with Taxol in the advanced lung cancer setting, as this new study builds on the Phase 1 study my team did with this combination,” said F. Anthony Greco, M.D., Medical Director, SCRI. “Platinum-based therapies are widely used to treat patients with advanced non-small cell lung cancer. Satraplatin, as an oral platinum-based compound that is well tolerated, could, if effective, be an important new option for treating patients with this disease.”
“SCRI is a renowned research support services organization that works in concert with the Sarah Cannon Cancer Center, the largest, privately-funded, community-based cancer treatment program in the U.S. Dr. Greco is a distinguished medical oncologist there who has been instrumental in developing new and improved therapies for cancer,” said Marcel Rozencweig, M.D., Senior Vice President, Drug Development of GPC Biotech. “The opening of this trial continues our strategy of initiating studies at highly regarded cancer centers to explore the potential of satraplatin in combination with other anticancer therapies and for the treatment of other cancers beyond the initial indication for second-line chemotherapy of hormone- refractory prostate cancer.”
Lung cancer is the leading cause of cancer death in the U.S., with an estimated 163,000 deaths expected from the disease in 2005. Over 170,000 new cases are expected to be diagnosed in 2005. The five- year survival rate for lung cancer in the U.S. is only 15 percent. Recent statistics for Europe estimated over 375,000 cases annually of lung cancer and over 345,000 deaths from the disease. NSCLC accounts for over 80 percent of all lung cancer cases.
About Satraplatin Satraplatin, an investigational drug, is a member of the platinum family of compounds. Over the past two decades, platinum-based drugs have become a critical part of modern chemotherapy treatments and are used to treat a wide variety of cancers. Worldwide sales of these drugs exceeded $2.2 billion in 2004. Unlike the platinum drugs currently on the market, all of which require intravenous administration, satraplatin is an orally bioavailable compound and is given as capsules that patients can take at home. An oral platinum drug could offer key advantages, including ease of administration and patient convenience, in a variety of applications. Satraplatin is in a Phase 3 registrational trial - the SPARC trial - as a second-line chemotherapy treatment for hormone-refractory prostate cancer (HRPC). GPC Biotech has completed a Special Protocol Assessment with the U.S. FDA and has received a Scientific Advice letter from the European regulatory authority, the European Medicines Agency (EMEA). The FDA has also granted fast track designation to satraplatin for this indication. Satraplatin was in-licensed from Spectrum Pharmaceuticals, Inc.
Phase 2 trials have been completed in HRPC, ovarian cancer and small- cell lung cancer. Promising early clinical results have also been shown when satraplatin is combined with radiation therapy, and a Phase 1/2 study evaluating this combination in patients with non- small cell lung cancer has been initiated. Several others studies evaluating satraplatin in combination with other therapies and in various cancers are underway or planned. Further information on satraplatin can be found in the Anticancer Programs section of the Company’s Web site at www.gpc-biotech.com.
About Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI), a company created by HCA and Tennessee Oncology, is dedicated to advancing solutions for a healthier tomorrow through clinical research. It is one of the largest, community-based research support programs offering management, regulatory and other research support services for strategic investigator sites across the country in ten therapeutic areas. SCRI works to provide greater access to oncology-related clinical trials in a community setting through a powerful network of 500 oncologists in 25 states.
About GPC Biotech GPC Biotech AG is a biopharmaceutical company discovering and developing new anticancer drugs. The Company’s lead product candidate - satraplatin - is currently in a Phase 3 registrational trial as a second-line chemotherapy treatment in hormone-refractory prostate cancer following completion of a Special Protocol Assessment by the U.S. FDA and receipt of a Scientific Advice letter from the European central regulatory authority, EMEA. The FDA has also granted fast track designation to satraplatin for this indication. Other anticancer programs include: a monoclonal antibody with a novel mechanism-of-action against a variety of lymphoid tumors, currently in Phase 1 clinical development, and a small molecule broad-spectrum cell cycle inhibitors program, currently in pre-clinical development. The Company also has a number of drug discovery programs that leverage its expertise in kinase inhibitors. GPC Biotech has a multi- year alliance with ALTANA Pharma AG working with the ALTANA Research Institute in the U.S., which provides GPC Biotech with revenues through mid-2007. GPC Biotech AG is headquartered in Martinsried/Munich (Germany). The Company’s wholly owned U.S. subsidiary has research and development sites in Waltham, Massachusetts and Princeton, New Jersey. For additional information, please visit the Company’s Web site at www.gpc-biotech.com.
This press release may contain projections or estimates relating to plans and objectives relating to our future operations, products, or services; future financial results; or assumptions underlying or relating to any such statements; each of which constitutes a forward- looking statement subject to risks and uncertainties, many of which are beyond our control. Actual results could differ materially depending on a number of factors, including the timing and effects of regulatory actions, the results of clinical trials, the Company’s relative success developing and gaining market acceptance for any new products, and the effectiveness of patent protection. There can be no guarantee that the SPARC trial will be completed nor that satraplatin will be approved for marketing in a timely manner, if at all. In addition, there can be no guarantee regarding the results of the satraplatin Phase 2 study in combination with paclitaxel in patients with advanced non-small cell lung cancer. We direct you to the Company’s Annual Report on Form 20-F, as amended, for the fiscal year ended December 31, 2004 and other reports filed with the U.S. Securities and Exchange Commission for additional details on the important factors that may affect the Company’s future results, performance and achievements. The Company disclaims any intent or obligation to update these forward-looking statements or the factors that may affect the Company’s future results, performance or achievements, even if new information becomes available in the future.
Taxol(r) (paclitaxel) is a registered trademark of Bristol-Myers Squibb Company.
For further information, please contact:
GPC Biotech AG Fraunhoferstr. 20 82152 Martinsried/Munich, Germany
Martin Braendle Associate Director, Investor Relations & Corporate Communications Phone: +49 (0)89 8565-2693 ir@gpc-biotech.com
In the U.S.: Laurie Doyle Associate Director, Investor Relations & Corporate Communications Phone: +1 781 890 9007 X267 usinvestors@gpc-biotech.com
Additional Media Contacts: In the U.S.: Euro RSCG Life NRP Matt Haines Phone: +1 212 845 4235 matthew.haines@eurorscg.com
In Europe: Maitland Noonan Russo Brian Hudspith Phone: +44 (0)20 7379 5151 bhudspith@maitland.co.uk
